A Phase 4 interventional study of Dexmedetomidine Injection [Precedex] in Intrathecal Dexmedetomidine, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-07.
Sponsored by Ain Shams University · Phase 4, Interventional, and Prevention
Background: Highly selective α-2 agonist dexmedetomidine in increasingly used as an intrathecal adjuvant for caesarean section performed under subarachnoid block.
Aim of the Study: The aim of the study is to determine whether low dose dexmedetomidine added to local anesthetic for spinal anesthesia will attenuate perioperative nausea and vomiting and shivering in lower segment caesarean section (LSCS) with minimal hemodynamic instability or not.
Patients and Methods: Sixty parturients planned for elective CSs under spinal anesthesia were enrolled in this prospective controlled study and randomly divided into two equal groups. Spinal block was achieved with 10mg hyperbaric bupivacaine 0.5% plus 5µg dexmedetomidine (group D) (dexmedetomidine group) or 0.2 ml normal saline (group C) (control group). Hemodynamic parameters, incidence of nausea and vomiting and shivering were recorded.
Keywords: Dexmedetomidine, Cesarean Section, Bupivacaine, Spinal Anesthesia, Shivering, PONV
Ain Shams University is the lead sponsor of 1,930 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
5 mcg dexmedetomidine intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Drug: Dexmedetomidine Injection [Precedex]
0.2 ml normal saline intrathecally injected with 10 mg hyperbaric bupivacaine during spinal anesthesia for caesarean section.
Drug: Dexmedetomidine Injection [Precedex]
intrathecal injection of 5 mcg dexmedetomidine
Effect of subarachnoid dexmedetomidine on hemodynamic parameters.
Measure heart rate, blood pressure, temperature, oxygen saturation
Time frame: Two hours
Effect of subarachnoid dexmedetomidine on incidence of postoperative nausea and vomiting (PONV) and shivering.
Note occurrence of postoperative nausea or vomiting and note occurrence of shivering and measure the degree.
Time frame: Six hours
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2021 to primary completion in Jan 2023, 19 months.
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine